From The Editor | December 29, 2017

Top 5 Biosimilar Developments Of 2017

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By Anna Rose Welch, Editor, Biosimilar Development

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Last year, the most popular article published on Biosimilar Development was, hands-down, the list of the top 5 developments for biosimilars in 2016. As the article gained traction over the first few weeks of January, I decided to make it an annual occurrence — not only because of its popularity, but because of the benefit it brings to me, as well, in reflecting on some of the broader changes we’ve seen in the industry over the past year.

Though I questioned back in January whether 2017 would be a standstill year for the biosimilar industry, after putting together a list of all that has transpired, it’s clear 2017 was actually a very big year for biosimilars. Now, one concession must be made: While figures from Sandoz’s Zarxio have quietly been on the rise, stories of uptake and market launches in the U.S. have been close to non-existent, despite the slew of approvals and application submissions.

If I had to characterize 2017, I feel this quote from Field of Dreams is most appropriate: “If you build it, they will come.” As you review my list, I think you’ll understand why I feel this way. These top five events reflect the steps the numerous industry stakeholders are taking to build what they hope will be a biosimilar friendly framework in the U.S. Though I feel a number of these developments could bring positive implications for the biosimilar industry moving forward, several of these have raised a number of questions and concerns. In keeping with last year, I left one big item off this list: The inauguration of the new political administration, including Scott Gottlieb’s appointment to head the FDA. These events have both benefited and challenged regulatory agencies and the whole pharmaceutical industry — not just biosimilars — and no doubt will continue to do so in the years to come.

5. The FTC Holds A Workshop On Anticompetitive Practices

It was unprecedented news that the FTC would hold a workshop focused on the anticompetitive practices plaguing the generics and biosimilar industries. Over the past year, we’ve heard increasing chatter about the alleged abuses occurring within the supply chain, including the lack of transparency regarding rebates and “middle man” profits. In addition to infographics and charts depicting the differing biosimilar and biologic development processes, the industry has now begun churning out visual aids highlighting the major players in the supply chain and the passage of money amongst them and revenues made. The FTC workshop brought together generics/biosimilar makers, pharmacy benefit managers (PBMs), group purchasing organizations, wholesalers, trade organizations, pharmacist organizations, and academicians to hear the wide variety of perspectives they bring to the table. Though the workshop was simply an introduction to current supply chain practices and issues, I felt it highly worthy of this list, especially because of the key role biosimilar companies have played in drawing attention to anticompetitive practices. (In fact, I’d argue that, thanks to the biosimilar industry’s persistence in calling attention to market barriers, the industry played a central role in bringing about this event.) The FTC was clear that anti-trust enforcement changes may not necessarily occur anytime soon (or at all). But getting the conversation started in a public forum is a notable start toward addressing barriers affecting biosimilars as the market matures.

4. Pfizer Sues J&J Over Alleged Anti-Competitive Practices

I would be remiss to not highlight the case I can only imagine will inspire a new trend in biosimilar/biologic litigation. I’ll admit to being somewhat surprised by this lawsuit, partially because Pfizer itself is an innovator company and has surely utilized some of the same practices J&J has. But if there is one takeaway from this as-of-yet unresolved case, it’s the lengths to which both innovator and biosimilar companies will go to get market share (and that a company’s hybrid business model doesn’t have to matter when it comes to biosimilars). J&J has been quite open about its biosimilar battle strategy involving exclusive contracts, bundling, and steep discounts to independent fusion centers. But seeing as 2017 was seemingly the year the pharma industry (and patients, for that matter,) began directing attention to market-barring practices, it was only a matter of time before a company took payer contracting strategies to the courts.

3. Amgen, AbbVie Reach Settlement For Amjevita Launch

In addition to 2017 being the year of new and ongoing legal battles, it also was the year we started seeing settlements. In March, we saw the first agreement occur between Mylan and Genentech. Mylan gained a global license to launch its trastuzumab biosimilar in all but a few markets (Mexico, Brazil, and Japan). But one settlement I personally didn’t see coming was the AbbVie-Amgen settlement nailing down Amjevita’s U.S. launch date in January 2023. Not only does this give AbbVie another six years of exclusivity (bringing the total up to 20 years), but it also poses a number of challenges moving forward for the biosimilar industry. One of these challenges is strictly from a business/competition side of things. It’s highly likely Amgen included a clause in the settlement that would enable it to launch Amjevita should another company succeed in launching its Humira biosimilar prior to 2023. As such, there’d be immediate competition for anyone who manages to escape through AbbVie’s patent maze unscathed (as mythical an event as there may be at this point). Similarly, should the U.S. not see the launch of a Humira biosimilar prior to 2023, we’re looking at a six-year period of no exposure to or experiences with biosimilars in that broad patient base. We can certainly hope an educational strategy is afoot and that real-world evidence will continue to promote more confidence in biosimilars to ease Amjevita’s market launch. But given Humira’s prominence on the market and its impressively large patient base, this length of time without exposure to the concept of biosimilars for a number of patients will likely be a stumbling point. This waiting period also raises questions about the pricing of the biosimilar, especially if Humira continues to increase in price over the course of six years.

2. The FDA Releases Its Interchangeability Guidance

After waiting years for the interchangeability guidance, the industry did not have to wait long into 2017 to figure out what the FDA had in mind. Though interchangeability did not raise many hackles immediately (unlike the still-controversial naming guidance), the longer the industry has had to sit with this guidance, the less positively it seems to be perceived. Earlier this year, I highlighted some of the challenges facing biosimilar developers looking to pursue interchangeability, including switching trials, real-world evidence, and human-use studies for devices. Overall, a prevailing attitude seems to be that the FDA has set a high bar which, ultimately, could serve as expensive red tape and deter companies from seeking interchangeability altogether. In addition to the aforementioned concerns, the regulatory designation has, unintentionally, led some to incorrectly assume interchangeable biosimilars are of higher quality than non-interchangeables, adding another delightful angle to the industry’s already complex biosimilar education efforts. At the end of the day, interchangeability may prove to be a valuable business strategy for a select few products for a select few companies that have the proper resources to carry out the development. But whether the release of this guidance will prove to be a productive addition to the U.S. market has yet to be determined.    

1. CMS Revises Medicare Part B Policy And Adjusts Medicare Part D

If there is one event that encapsulates the positive progress made in the biosimilar industry this year, it’s CMS’ complete reversal in regard to its Part B legislation. As I discussed in a recent article, providing each biosimilar with its own unique J-code has been on the industry’s wish list since CMS first released its Medicare Part B biosimilar policy in 2016. I’ve ranked this development number one in my list because it is best in-keeping with the quote, “If you build it, they will come.” Prior to this policy change, companies expressed concern that steep price cuts ultimately would lead players to exit the biosimilar market altogether. Now, the industry expects this change will entice future manufacturers to take part in the biosimilar market, increasing competition and patient choices. In addition, this change will keep much-needed patient assistance programs safe from being cut, which could’ve happened in a race-to-the-bottom pricing scenario under the former policy. But in addition to the Part B proposal, I was also drawn to some of the work the agency did in regard to its existing Part D policy. While the industry has yet to see the agency fix the coverage gap issue in existing policy, I appreciated the agency’s discussion on how to pass rebates to patients at the point of sale (POS). As I argued in a recent article, this proposal could be key to realizing biosimilars’ promise of passing much-needed savings on to patients.

2017 Honorable Mentions

Though these top five developments were heavy-hitting events in the U.S. biosimilar space in 2017, there were a number of other occurrences in the U.S. and abroad I felt deserved attention. Many of these also hold the potential to influence the shape of the overall market and/or signify larger trends and overall market growth. These are listed in no particular order.

  • The second version of the Biosimilar User Fee Act (BsUFA II) was signed into law. In keeping with the FDA’s promise in the Act to hire additional staffing for biosimilar reviews, the agency had an external contractor evaluate the hiring process. Though the FDA has its work cut out for it, the agency has established a method with which to begin implementing the necessary changes to its hiring practices.
  • The Supreme Court issued its final ruling on Amgen vs. Sandoz, keeping the patent dance optional and permitting the 180-day notice of commercial marketing to be given prior to FDA approval.
  • The FDA announced its biosimilar educational initiative.
  • The U.K.’s National Health Service (NHS) published its highly anticipated Commissioning Framework for Biological Medicines (including biosimilar medicines). This framework lays out goals to have 90 percent of new patients prescribed the “best-value biological medicine” (key words here) within three months of a biosimilar launch, and 80 percent of existing patients within the next year.  
  • A group of European regulators published an article in BioDrugs proclaiming that EU-licensed biosimilars are interchangeable. (These authors relied upon current knowledge and real-world evidence, not additional regulatory bells and whistles, to make this determination).
  • Samsung Bioepis and partner Merck & Co. launched the second infliximab biosimilar, Renflexis, in the U.S. at a whopping (for the U.S.) 35 percent discount.
  • The WHO reversed its original proposal for a worldwide biosimilar naming convention, eliminating the call for additional four-letter biological qualifiers and two-digit check-sums.
  • Express Scripts added Zarxio to its formulary, excluding Neupogen. However, a majority of payers, outside of UnitedHealthcare, did not include Inflectra and Renflexis on their formularies. (UnitedHealthcare kept Remicade as its preferred product.)
  • The FDA released its final Non-proprietary Naming of Biologics and Biosimilars guidance and its Statistical Approaches to Evaluate Analytical Similarity draft guidance.
  • The Generic Pharmaceutical Association (GPhA), rebranded to become the Association for Accessible Medicines (AAM).
  • Ireland, which has one of the lowest biosimilar uptakes in the EU, finally announced its intent to bolster the use of biosimilar medicines in the country. The Department of Health released a National Biosimilar Medicines Policy consultation paper in August 2017. This paper explores education, pricing, and incentivizing systems used in other countries to gather stakeholder views on how best to implement a biosimilar friendly framework in Ireland.       
  • The WHO announced its plans to begin a pilot prequalification of biosimilars for rituximab and trastuzumab in order to expand access to these drugs in low- and middle-income countries. In fact, at the 2017 DIA Biosimilars conference, this program led to an interesting discussion on the use of the global reference product, which would eliminate the need for comparator bridging studies and better streamline biosimilar development.